BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2023003 · Received February 24, 2011

    Report

    Report Number
    1644487-2011-00336
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: MFR REVIEW OF X-RAYS REVEALED THAT THE LEAD PIN APPEARED TO BE FULLY INSERTED INTO THE GENERATOR.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2011 THAT A VNS PATIENT HAD BEEN RECENTLY IMPLANTED 2 WEEKS PRIOR, BUT NOW A SYSTEM DIAGNOSTIC TEST REVEALED HIGH IMPEDANCE, WHICH WAS GREATER THAN 10 KOHMS, X-RAY IMAGES WERE TO BE TAKEN, AND THE DEVICE WAS GOING TO BE DISABLED AS WELL. THERE WAS NO REPORT OF TRAUMA FROM THE DOCTOR, BUT THE PT WAS SAID TO BE A "VERY ACTIVE KID." F/U WITH THE DOCTOR'S OFFICE WAS OBTAINED AND IT WAS STATED THAT X-RAYS HAD BEEN TAKEN, BUT NO FRACTURE WAS OBSERVED. THE PT HAD BEEN SENT FOR A REPLACEMENT. IT WAS EXPLAINED THAT THE LEAD PIN SHOULD BE REINSERTED AS A FIRST ATTEMPT AT RESOLVING THE ISSUE, ESPECIALLY GIVEN THE LENGTH OF IMPLANT OF THE PT. THE PATIENT'S X-RAYS WERE REC'D BY THE MFR, AND THEY WERE REVIEWED ON THE DATE OF THE REPLACEMENT SURGERY. NO CLEAR DISCONTINUITY WAS OBSERVED; HOWEVER, A SUSPECT AREA WAS IDENTIFIED IN THE LEAD BODY WHERE ITS FINAL CAUDAL TURN IN THE CERVICAL REGION TOOK PLACE. THE REPLACEMENT SURGERY TOOK PLACE AND THE SURGEON REPLACED THE PATIENT'S GENERATOR ONLY. RESULTS OF DIAGNOSTICS WITH THE NEW GENERATOR IN PLACE WERE WITHIN NORMAL LIMITS WITH AN IMPEDANCE OF 3.400 KOHMS. A GENERATOR DIAGNOSTIC TEST WAS PERFORMED ON THE EXPLANTED GENERATOR WITH A TEST RESISTOR IN PLACE, WHICH SHOWED 3.457 KOHMS. THE SURGEON HAD NOT ATTEMPTED TO REINSERT THE LEAD PIN INTO THE OLD GENERATOR AS THE X-RAYS HE VIEWED SHOWED THE CONNECTOR PIN TO BE FULLY INSERTED. THE EXPLANTED GENERATOR WILL BE RETURNED TO THE MFR ONCE PROCESSED BY THE EXPLANTING HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2779

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR